MCCULLEY CONTINUOUS SUTURE TIGHTNER— 510(k) K801608

Name: FDA 510(k) clearance K801608
Creator: U.S. Food and Drug Administration
Published: 1980-08-12

Substantially Equivalent

Edward Weck, Inc.

FDA 510(k) clearance K801608 for MCCULLEY CONTINUOUS SUTURE TIGHTNER, Substantially Equivalent on 1980-08-12. Applicant: Edward Weck, Inc.. Device class: 1.

Clearance details

Applicant: Edward Weck, Inc.
Product code: Code HND
Device class: Class 1
Regulation: 21 CFR 886.4350
Advisory panel: Ophthalmic
Date received: 1980-07-15
Decision date: 1980-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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